Assessing Success of MTA and Pre-mixed Bioceramic in Mature Teeth With Irreversible Pulpitis With Full Pulpotomy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Clinical Success at 6 Months
研究概览
简要总结
Although many pulpotomy agents are commercially available, there is a dearth of clinical research comparing the efficacy of these agents in treating individuals with irreversible pulpitis. Bioceramic and MTA both have similar clinical uses, but Bioceramic is distinguished from MTA by its superior chemical, physical, and biological properties. This study aims to address this knowledge deficit by assessing the performance of biocompatible materials in pulpotomy procedures for the treatment of symptomatic permanent teeth in adults with deep caries. For permanent teeth with a completed root and a diagnosis of irreversible pulpitis without apical periodontitis, this research will compare the success rates of MTA and EBRRM pulpotomy procedures in order to provide evidence-based clinical practice guidelines for the treatment of this disease.
详细描述
The goal of this observational study is to test and compare the success of full pulpotomy with Mineral Trioxide Aggregate (MTA) pre-mixed bioceramic in mature teeth with irreversible pulpitis. Participants in this study were patients with irreversible pulpitis without apical periodontal pathosis recruited from the waiting list at the School of Dentistry at Liaquat University of Medical and Health Sciences in Jamshoro. After obtaining informed consent, demographic information, clinical examination results, and binary variables were recorded pre- and intra-operatively. The study's primary aim was to assess postoperative pain, and secondary aims included assessing the presence of swelling, sinusitis, or fistula and detecting tooth mobility. Participants received either MTA or Endo Sequence Bioceramic Root Repair randomly allocated using a lottery system. Follow-up assessments were done initially, after 6 days, and after 6 months, and periapical radiography was done at 6 days and 6 months to detect radiolucency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 10 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with diagnosis of irreversible pulpitis without apical periodontitis
- •Either gender
- •Lower Age 10 Years - Upper Age 40 Years
排除标准
- •Teeth displaying indications of resorption.
- •Teeth that have not fully developed, characterized by open apices.
- •Canals that are calcified or obstructed.
- •Perforations that were caused by the dentist.
- •Fractures in the root
- •Teeth that cannot be restored
- •• Teeth that are unable to withstand frigid temperatures, have a sinus infection, or have swelling around them.
- •There has been no pulp exposure despite the removal of carious lesion.
- •Ten minutes after a pulpotomy, hemorrhage could not be stopped.
- •Necrotic or partly necrotic pulp is indicated by insufficient bleeding after exposure.
研究组 & 干预措施
Pro Root MTA®
Patients in this group will receive the pulpotomy with Pro Root MTA®.
干预措施: Pro Root MTA® (Drug)
EBRRM®
Patients in this group will receive the pulpotomy with Endosequence Bioceramic Root Repair Material (EBRRM)®.
干预措施: EBRRM® (Drug)
结局指标
主要结局
Clinical Success at 6 Months
时间窗: 6 Months
Number of participants with clinical success based on following criteria * No complaints of pain or discomfort outside of the initial two days following therapy. * The tooth shows no signs of pain upon palpation or percussion. * A probing pocket depth of less than 4 mm and 1 mm are indicative of normal movement. * No inflammation or sinus tract can be seen in the soft tissues around the teeth.
次要结局
- Radiographic Success(6 Months)
研究者
Sarang Suresh
Principal Investigator
Liaquat University of Medical & Health Sciences